- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07828275
FASD Prevention R33 (R33)
14 de septiembre de 2026 actualizado por: Yukiko Washio, Philadelphia College of Osteopathic Medicine
Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)
This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA).
SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure.
FASD is completely preventable if women do not drink during pregnancy.
Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis.
The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone.
Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects.
Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use.
Alcohol use while breastfeeding also occurs at a relatively high rate in SA.
Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development.
Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.).
The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use.
These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
184
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yukiko Washio, PhD
- Número de teléfono: (215) 871-6100
- Correo electrónico: yukikowa@pcom.edu
Ubicaciones de estudio
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Cape Town, Sudáfrica
- University of Cape Town
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Contacto:
- Heather Jaspan, MD, PhD
- Número de teléfono: +27 21 650 9111
- Correo electrónico: hbjaspan@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.
Exclusion Criteria:
- Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Usual Care
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back.
R200 will be provided for sample provision.
Research staff will make referrals to treatment programs in the community as needed.
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Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back.
R200 will be provided for sample provision.
Research staff will make referrals to treatment programs in the community as needed.
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Experimental: Intervention
Participants will receive text-based support on health promotion and referral content based on educational components.
Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
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Participants will receive text-based support on health promotion and referral content based on educational components.
Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Urinalysis results for alcohol use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
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An alcohol metabolite (EtG) will be measured in urine samples.
EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking with ≥150 ng/mL for EtG as a cutoff value.
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From enrollment to the end of treatment at 3 months postpartum
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Urinalysis results for tobacco use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
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Biochemical verification of recent tobacco use in urine samples.
A tobacco metabolite (cotinine) will be measured in urine samples.
The metabolite can be detected up to 3-4 days after use with ≥ 80ng/mL as a cutoff.
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From enrollment to the end of treatment at 3 months postpartum
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Urinalysis results for cannabis use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
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Biochemical verification of recent cannabis use in urine samples.
A cannabis metabolite (THC) will be measured in urine samples.
The metabolite can be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff.
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From enrollment to the end of treatment at 3 months postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Birth weight
Periodo de tiempo: Birth
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Birth weight
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Birth
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Gestational age at birth
Periodo de tiempo: Birth
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Gestational age at birth
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Birth
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Head circumference
Periodo de tiempo: Birth
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Head circumference
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Birth
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Apgar score
Periodo de tiempo: Birth
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Apgar score
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Birth
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NICU admission
Periodo de tiempo: Birth to 3 months postpartum
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NICU admission and length of stay
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Birth to 3 months postpartum
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Infant weight at 3 months
Periodo de tiempo: 3 months postpartum
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Infant weight at 3 months
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3 months postpartum
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Infant height at 3 months
Periodo de tiempo: 3 months postpartum
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Infant height at 3 months
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3 months postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de febrero de 2027
Finalización primaria (Estimado)
31 de enero de 2029
Finalización del estudio (Estimado)
30 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H26-046
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
A limited data set in which names and other personal health identifiers are removed will be supplied to researchers on request.
The data will be made available after the publication of the study results.
Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels.
Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the principal investigator and the team for review, if appropriate.
The data sets will be ready for use and can be converted to other analytic tools.
Marco de tiempo para compartir IPD
After study outcomes are published for 3 years
Criterios de acceso compartido de IPD
those with the permission of the principal investigator and the team investigators
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .